RRisk management

Our Pharmacovigilance services includes a team of industry experts in the field of Risk Management planning and strategy, many with FDA and MHRA backgrounds.

We can help your organization with

  • Data and dictionary management
  • Pre-registration development
  • Post-approval product safety studies
  • GxP Compliance Strategies
  • GxP audits
  • Pre-approval inspection (PAI) readiness
  • Operational readiness and sustainability programs (mentoring)
  • Assistance during inspections/post-inspection correspondence and meetings
  • Assistance to legal counsel in FDA enforcement matters
  • Due diligence of product and facility acquisitions
  • Training in GxP compliance and topical issues